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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 32603
Product Type Biologics
Status Ongoing
Recalling Firm One Lambda Inc
City Canoga Park
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB Only Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP2LB Lot Number: 004 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 1 B-1426-13
Micro SSP DNA Typing Trays Micro SSP High Resolution HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP2H Lot Number: 04A and 005 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 2 B-1424-13
Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*26 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP1-26 Lot Number: 01A Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 1 B-1423-13
Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*11 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP1-11 (Lot Number: 002) and SSPR1-11 (Lot Number: 003). Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 2 B-1422-13
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSP2L Lot Number: 007 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 1 B-1425-13
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class I and II DNA Typing Tray - ABDRDQ Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSPML02 Lot Number: 003 and 004 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 2 B-1429-13
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB/DQB1/DPB1 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSPDRQP1 Lot Number: 001 Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 1 B-1428-13
Micro SSP DNA Typing Trays Micro SSP HLA Class I and II ABDR DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062 Catalog Identification: SSPABDR (Lot Number: 008 and 009) and SSPABDRX (Lot Number: 008 and 009) Class III Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed. 4 B-1427-13
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